5 November 2015

Maintaining a Quality Management System

In the first of a series of blogs on ERP systems in Life Sciences I’m going to take a look at one of the critical success (or failure) factors – which is a broader topic I’m sure I’ll return to in the coming months.
I first got involved in ERP implementations in the final few years of the 20th century and since then I’ve literally lost count of the number of Life Sciences ERP projects I’ve been involved with. I’d also struggle to list the number of different ERP systems and vendors I’ve been involved with.
Most of these projects have been successful, all have had their challenges but some have had real problems – and a common problem I see is lack of buy-in from the Quality / Regulatory teams, especially in small-to-medium enterprises implementing ERP systems for the first time.
Many small-to-medium enterprises have a limited number of products, a limited number of manufacturing sites and relatively small manufacturing volumes.
All of this makes it possible to develop and maintain a Quality Management System (QMS) based on paper and/or using unstructured electronic records (i.e. spreadsheets / small databases), which is what many small enterprises are using prior to moving to ERP.
In other cases medium sized companies may have implemented a standalone QMS system handling inspection results, supplier and internal audits, CAPA etc – which is increasingly in the Cloud.
Once these systems are set up and working it is natural that they are relied upon by the Quality Unit, but when an ERP system is implemented there is often a reluctance to move the quality processes to the ERP system, often in the mistaken belief that the ERP system is ‘non-compliant’ (with respect to e.g. 21CFR Part 11 / Annex 11), or because of the belief that the ERP system was never designed to manage QMS processes.
While it’s true to say that the QMS functionality in ERP systems was somewhat limited in the past, most reputable ERP systems are now perfectly capable of managing core QMS processes in a compliant manner, requiring relatively simple configuration to meet the quality management needs of even the pharmaceutical and medical devices sectors. While functionality may not be quite as good as ‘best of breed’ standalone QMS systems, the QMS functionality in most modern ERP systems is certainly good enough for most small-to-medium Life Sciences companies.
The beauty of including QMS processes within the scope of the ERP implementation is the integration with a common set of product, supplier and customer master data and transaction data from the manufacturing processes. This makes it much easier to associate quality data with other data, making for faster CAPA management, virtually instantaneous product traceability, easier approved supplier management, speedier product recalls etc. That’s the advantage of an ERP system – it’s designed to cover the entire Enterprise, not just separate silos.
I’ve seen a number of small-to-medium (and some not-so-small) enterprises choose not to implement their QMS processes in their new ERP – often driven by a reluctance on behalf of the Quality Unit. While this may be acceptable in the short term, most small-to-medium companies invest in ERP to support business growth – which can often be extremely rapid as new products receive regulatory approval, new markets are opened up through collaborative licensing deals or additional companies are acquired.
That’s when the spreadsheets and paper-based systems are most likely to fall apart and when Quality staff realise that they need a solution that will operate across multiple sites. While a standalone QMS can still scale and can still be used from different locations it still lacks integration with the ERP system. While it is technically possible to interface QMS and ERP systems, this isn’t as easy as people think and I genuinely can’t think of an organisation that’s done a good job of this.
Based on the experiences of a number of companies who have subsequently had to bite the bullet and later add QMS processes into their ERP system my advice is always be to plan this from the beginning. Even if it isn’t in Phase 1 of your ERP roadmap, integrating Quality with Manufacturing within the ERP system is an important part of the Return on Investment in a highly regulated industry such as Life Sciences. It should always be a strategic part of the roadmap and shouldn’t be left too late.
By David Stokes
Global Lead Life Science